top of page
Glossary Term
Design Review
Definition
A Design Review is a formal and documented assessment of a medical device’s design conducted at defined stages of the development process. It involves cross-functional stakeholders to ensure that the design meets user needs, regulatory requirements, and design inputs while identifying and addressing any potential issues.
Relevance to the MedTech Industry
Design reviews ensure the safety, quality, and regulatory compliance of medical devices by systematically evaluating the design throughout the development lifecycle. They facilitate collaboration, enhance traceability, and reduce risks by addressing issues early in the process.
Additional Information & Related Terms
bottom of page